MAUDE Adverse Event Report: EMBECTA MEDICAL I LLC - HOLDREGE, NE SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG; Syringe, Piston

Model Number	324910
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
From: (b)(6) sent: tuesday, june 25, 2024 1:39 am to:(b)(6) subject: direct consumer 2024-06-17 product inquiry - inquiry ref: "[ ref:!00d300y0yr.!5008a02zen2j:ref ]" from: (b)(6) sent: tuesday, june 25, 2024 1:39 am to: (b)(6) subject: direct consumer 2024-06-17 product inquiry - inquiry ref: "[ ref:!00d300y0yr.!5008a02zen2j:ref ]" direct consumer 2024-06-24 product inquiry - inquiry ref: consumer reported could not draw his insulin because he believes the needles are blocked.Lot: 3128169 catalog: 324910 date of event: 2024-06-24 samples: no 3 syringes affected declined to provide address and declined replacement.Email came into outlook but did not come into salesforce.Cl tmaik see email for date of event correction: date of event - (b)(6), 2024.

• Brand Name: SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG
• Common Device Name: Syringe, Piston
• Manufacturer (Section D): EMBECTA MEDICAL I LLC - HOLDREGE, NE
• Manufacturer Contact: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 50927101
• Report Number: 3024508819-2026-00272
• Device Sequence Number: 18825135
• Product Code: FMF
• UDI-Device Identifier: 00382903249107
• UDI-Public: 00382903249107
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K212499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 324910
• Device Lot Number: 3128169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Male